Cleared Abbreviated

K002168 - ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE

K002168 is an FDA 510(k) clearance for ASPIJECT SELF-ASPIRATING DENTAL INJECTI..., manufactured by Ronvig Instruments, Ltd.. The device is a Class 2 Dental device with product code EJI cleared through the Abbreviated 510(k) pathway after a 88-day FDA review.

K002168 · Ronvig Instruments, Ltd. · Dental device
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Oct 2000
Decision
88d
Days
Class 2
Risk

K002168 is an FDA 510(k) clearance for the ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Ronvig Instruments, Ltd. (Dk-8721 Daugaard, DK). The FDA issued a Cleared decision on October 13, 2000 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6770 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K002168

510(k) Number K002168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2000
Decision Date October 13, 2000
Days to Decision 88 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 128d · This submission: 88d
Pathway characteristics
Standards-based clearance path.

EJI Device Classification - Class 2, Special Controls

Product Code EJI Syringe, Cartridge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EJI Syringe, Cartridge

All 44
Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K002168.
EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES
K040671 · Anthogyr · Dec 2004
SAFETYWAND DISPOSABLE HANDPIECE
K023722 · Spintech, Inc. · Sep 2003
SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1
K022959 · MDC Research , Ltd. · Feb 2003
COMFORT CONTROL SYRINGE SYSTEM
K002387 · Dentsply Intl. · Sep 2000
WAND PLUS
K992819 · Spintech, Inc. · May 2000
MINIJECT
K991888 · Spartan Ultrasonics, Inc. · Aug 1999
K002168 · ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE
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